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According to a settlement just reached by Apple Computer Inc. wi

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

th Creative Technology Ltd., Apple has acknowledged that they we

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

e not the first with the patent to the software and systems that

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

make their MP3 players work.

Maybe Apple was not the first with

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

the technology but, they certainly have laid out the best adver

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ising campaign for their iPod mp3 players. So much so that the t

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

e word iPod has come to designate any make and model of mp3 play

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

er on the market today. Apple has also sold more than 1 billion

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

usic and video downloads through its online music store, iTunes.

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

Apple has grabbed over 75% of the mp3 player market while Creati

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

e has struggled to get into the double figures.

In the future,

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

Apple will pay for a license to use Creative's patent. Creative,

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

in turn, will be able to design iPod accessories, such as speake

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

s and earphones. Sim Wong Hoo, chairman and chief executive of C

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

reative, noted that the much smaller company's business stands t

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

benefit from its alliance with the market leader.

The real adv

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ntages of this alliance between Apple and Creative and how it wi

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ll affect the market and sales of mp3 players may lead to other

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ergers or patent agreements between the other manufacturers of m

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

3 players, such as, Sony, Sandisk, Samsung, Rio, iRiver, and RCA

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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